Ion Exchange Chromatography Resins

Ion exchange resins are used to purify biomolecules by separating them based on their surface charge. They are applied in capture and polishing steps for antibodies, plasmid DNA, viral vectors, and recombinant proteins. They can also be used in flow-through mode to help reduce impurities such as DNA, viruses, host cell proteins, and product and process-related impurities.

Ion exchange chromatography is used in the purification of advanced modalities, including viral vectors, plasmid DNA, and vaccines. Depending on the process, it functions in bind/elute mode for product capture or in flow-through mode to reduce impurities and separate product variants.

Anion exchange resins carry positively charged groups and bind negatively charged biomolecules such as DNA, plasmid, or viruses. Cation exchange resins carry negatively charged groups and bind positively charged molecules, such as antibodies or proteins with a high isoelectric point.

Resin choice depends on the molecule’s net charge at the operating pH and which impurities need to be reduced. Biomolecules vary in net charge depending on their isoelectric point (pI). Below the pI, a protein carries a positive charge and binds to a cation exchanger. Above the pI, it carries a negative charge and binds to an anion exchanger. Additional factors such as surface chemistry, particle size, pore size, as well as process requirement also influence resin selection.

POROS ion exchange chromatography resins are supplied in formats intended for use in cGMP production environments and have been implemented in multiple regulatory-approved manufacturing processes. Documentation is available to support regulated processes.

POROS resins use a poly(styrene-divinylbenzene) backbone, which enables reproducible scale-up and chemical stability for cleaning. Their pore structure facilitates high capacity and resolution across a wide range of flow rates. A 50-micron bead size improves resolution with tighter peaks and smaller elution volumes, supporting efficient downstream processing.

Thermo Fisher Scientific offers a range of chromatography products beyond cation exchange resins. Our portfolio includes affinity, anion-exchange, hydrophobic interaction, and mixed-mode resins. These resins can be applied to typical therapeutic biologic workflows such as antibody, protein, nucleic acid, and viral vector processing.

IEX resins are applied across multiple modalities to enable efficient separation and purification based on molecular charge:

• mAb bioprocessing solutions reduce process-related impurities and enhance product purity
• Gene therapy bioprocessing solutions are applied for viral vector purification
• mRNA bioprocessing solutions can help further reduce impurities
• Vaccine bioprocessing solutions support antigen capture and downstream purification
• Cell therapy bioprocessing solutions enable the preparation of ancillary materials with controlled quality attributes

They are also used in related applications, such as plasma fractionation and exosome purification. This flexibility helps streamline workflows from process development through cGMP manufacturing.

Yes, samples for evaluation can be requested through the Biotherapeutics Purification Sample Request Form.